Just months after the U.S. Food and Drug Administration (FDA) recommended a black box warning be placed on the safety labels of the permanent birth control device Essure in response to thousands of complaints, Health Canada announced it would be conducting a safety review of the controversial contraceptive.
Essure, made by Bayer Healthcare, is the only non-surgical permanent birth control method available in Canada or the U.S. It consists of two nickel alloy coils that are implanted in the fallopian tubes. The coils work with the body to form a scar tissue barrier that prevents the sperm from reaching the egg.
The devices have been linked to tens of thousands of complaints in both countries involving allergic reactions, autoimmune responses, chronic pain and infections. The coils can also migrate and perforate the fallopian tube or uterine wall, and puncture other organs. Essure has also been linked to dozens of fetal deaths and a handful of maternal deaths.
Hundreds of women in both the U.S. and Canada have filed lawsuits against Bayer alleging the company did not adequately warn the public of Essure complications.
A massive social media campaign uniting thousands of Essure users who say they were injured by the device persuaded the FDA to conduct a Safety Review. In February 2015, the agency recommended a black box warning be added to the contraceptive and required Bayer to collect additional safety data for Essure.
Health Canada expects its review of Essure to be completed by the end of spring 2016. “If at any time a new risk to health is identified, Health Canada will take the appropriate action to protect the health and safety of Canadians,” the agency told Global News.
Source: Global News